Patients Undergoing Balloon Angioplasty Research Articles

Correction of Coarctation of Aorta in Adult Patients - Impact of Corrective Procedure on Long-Term Recoarctation and Systolic Hypertension

Uncorrected coarctation of the aorta in adults predisposes to congestive failure, aortic rupture, stroke and endocarditis. Surgical correction of this condition is fraught with technical difficulties due to the complexity of the lesion, associated anomalies and extensive collaterals. The optimal surgical technique has not yet been well defined in adults. We describe our experience with adult coarctation and the long-term outcome with regard to recoarctation and systolic hypertension. A consecutive series of 54 patients above the age of 12 years who underwent coarctation correction over a period of 8 years are included in this report. Eight patients underwent balloon angioplasty, one of whom also had stent placement. Forty-eight patients underwent surgical intervention. Twenty-seven patients underwent resection and anastomosis, 6 had patch angioplasty and 13 had a prosthetic graft repair. All patients were followed up at 3 months and then annually to look for recoarctation, regression of hypertension and aneurysm formation. There was no mortality in this series; major morbidities included reoperation for bleeding in 3 patients, pulmonary complications and paraplegia in 1 patient. Hypertension was well controlled in all patients at discharge. Follow-up is 100 % complete and mean follow-up was 4.6 years. There was one case of aortic dissection and one case of aneurysm formation in the balloon angioplasty group. There was a statistical trend towards increased rates of recoarctation in the balloon and resection and anastomosis groups. 32 % of patients were off antihypertensive medications at their last follow-up. Surgical correction of coarctation of aorta in adults can be achieved with an acceptable morbidity. A variety of options are available for the surgical management of coarctation of the aorta in adults. Prosthetic graft and patch repair are associated with good short and long-term results. Use of balloon angioplasty without stenting as the primary therapy requires further clarification. Hypertension is well controlled in most patients.

Is Surgical Thrombectomy to Salvage Failed Autogenous Arteriovenous Fistulae Worthwhile?

The Dialysis Outcomes Quality Initiatives guidelines emphasize placement of autogenous arteriovenous (AV) fistulae for patients on hemodialysis. This recommendation is based on studies that demonstrate enhanced patency for AV fistulae compared with grafts. However, closer review of the data demonstrates that although primary patency of AV fistulae is superior to grafts, the secondary patency rates are equivalent. This suggests that secondary procedures to maintain fistula patency are inferior to those performed on arteriovenous grafts. Surgical thrombectomy of AV fistulae can be challenging. It is often difficult to completely remove thrombus adjacent to the anastomosis of the fistula, and pseudoaneurysms within the fistula can prevent passage of the thrombectomy catheter and complete removal of thrombus from the fistula. Consequently, some surgeons simply abandon thrombosed AV fistulae and place a new access. We have developed a method for completely clearing thrombus from failed AV fistulae by locating the fistulotomy close to the arterial anastomosis and using a technique to manually extract thrombus from the fistula before passing a thrombectomy catheter. The purpose of this study was to review our results with this procedure. Between 2001 and 2004, 10 patients with a previously functioning AV fistula presented with thrombosis. There were seven brachiocephalic fistulae and three radiocephalic fistulae. All patients underwent surgical thrombectomy and fistulography. Five patients underwent balloon angioplasty of a venous stenosis and one patient underwent surgical revision of an arterial stenosis. Technical success, defined as being able to completely clear thrombus from the fistula and treat the cause for fistula failure, was achieved in 70 per cent (7/10) of cases. Technical failure was caused by vein rupture during the balloon angioplasty in two cases and a central venous occlusion that could not be treated in one case. The 6-month primary and secondary patency for cases that were technically successful was 51 and 69 per cent, respectively. Our conclusion was that surgical thrombectomy can significantly extend fistula functionality in patients who present with thrombosis.

Combined Endovascular and Surgical Treatment of Infected Carotid-Carotid Bypass Graft

To present a complex case involving an infected carotid-carotid bypass graft that was successfully treated with a stent-graft and subsequent surgical removal of the infected graft. A 75-year-old woman presented with persistent purulent drainage of an infected and exposed carotid-carotid prosthetic bypass graft. Wound cultures revealed methicillin-resistant Staphylococcus aureus. She was treated with appropriate intravenous antibiotic therapy without improvement in wound drainage. Because of her comorbid conditions, a decision was made to pursue endovascular revascularization of her left and right common carotid arteries (CCA), with subsequent surgical removal of the infected prosthetic graft. The patient underwent balloon angioplasty; a 7x18-mm Omnilink stent was deployed in the innominate artery and a 7x18-mm Herculink stent in the ostial left CCA. During the same procedure, the carotid-carotid bypass graft was excluded with deployment of an 8x50-mm Viabahn stent-graft in the right CCA. Several days later, the infected and now thrombosed carotid-carotid bypass graft was surgically removed, and an area of adjacent muscle was used to patch the previously excluded connection of the bypass from the right CCA. A saphenous vein patch was used to repair the defect in the left CCA. Her postoperative course was uneventful. At 1 year, the clinical and duplex examinations revealed satisfactory wound healing and patent left and right CCAs. This case indicates that a combined endovascular and surgical approach may be a safe and effective option in the treatment of carotid-carotid bypass graft infection.

Endovascular Approaches for Complex Forms of Recurrent Aortic Coarctation

To review a single-center experience with endovascular treatment of recurrent aortic coarctation in adults. Since 1998, 11 patients (9 men; mean age 48+/-15 years, range 16-63) with recurrent aortic coarctation following previous coarctation repair were referred to our institution for treatment. Clinical presentations included pseudoaneurysm (n=2), restenosis (n=3), pseudoaneurysm accompanied by restenosis (n=4), and rupture of a post-coarctation pseudoaneurysm (n=2). All patients were treated using an endovascular approach as part of a single-center investigational device exemption protocol. Endovascular interventions included Palmaz stent implantation (n=3), implantation of an endoluminal graft (n=2), or a combination of both treatments in 6 patients. Three patients underwent balloon angioplasty before stenting or endografting, and 2 patients had a carotid-subclavian bypass done before the endovascular repair. All repairs were technically and clinically successful. The median length of stay after repair was 2.0+/-2.3 days. In follow-up, 2 patients underwent a carotid-subclavian bypass for left upper extremity claudication. Two patients required reintervention owing to migration of the stent in 1 and an endoleak 2 years after the initial procedure in the other. Endovascular approaches to adult coarctation appear to be safe and effective. With the emergence of endoluminal grafts and the widespread availability of the Palmaz stent, endovascular repair offers an excellent alternative to open surgery for complex cases of recurrent coarctation. Additional studies are indicated to assess the long-term outcomes of these patients.

Impact of Age on the Outcomes of Women Following Percutaneous Coronary Intervention in the Bare‐Metal Stent Era

Advanced age and female gender are both independent predictors of early and late mortality and adverse cardiac outcomes for patients undergoing balloon angioplasty. Elderly women are at particular risk. Stenting is now the standard of care in PCI. Whether elderly women remain at increased risk after PCI in the current stent era has not been examined widely. Prospective data were collected in 400 consecutive female patients undergoing PCI at a tertiary cardiac center (1999-2003). Follow-up was done at 1 month, 6 months, and 12 months by clinic visits, telephonic interviews, and reviewing hospital records. Follow-up was complete in 396 patients. Compared to young women (<65 years old), elderly women (>65 years old) were less likely to smoke (15.7% vs 47.2%, P = 0.001), less likely to have diabetes (4.1% vs 8.5%, P = 0.05), and had more multivessel coronary artery disease. Usage of stent was high, similar in both groups. Hypertension, hypercholesterolemia, previous MI, vessels treated, abciximab usage, and access site bleeding were similar in both groups. Procedural success (96% vs 98%) and in-hospital and 1-year MACE (23.1% vs 25%) are similar in both groups. Elderly women undergoing PCI have a distinct profile presenting with more multivessel disease, less smoking, and are less likely to have diabetes than younger women. In the current stent era, procedural success, in-hospital adverse cardiac events, and MACE at 1 year are similar in both groups. At 1 year, however, elderly women are less likely to have ischemia-driven TVR and recurrence of angina.

Endovascular Brachytherapy After Femoropopliteal Balloon Angioplasty Fails to Show Robust Clinical Benefit Over Time

To determine if the short-term efficacy of adjunctive endovascular brachytherapy (EVBT) is maintained over time in patients undergoing balloon angioplasty (BA) of femoropopliteal atherosclerotic lesions. To evaluate the long-term clinical and angiographic outcome of EVBT, 147 consecutive patients (82 men; mean age 70.8+/-8.5 years) with 147 treated limbs were randomized to BA with (n=72, 49%) or without (n=75, 51%) adjunctive EVBT (12 or 14-Gy from an (192)Ir source, no centering, a 5-mm reference depth). Sixty-eight (46%) limbs were treated for de novo and 79 (54%) for recurrent femoropopliteal lesions. Clinical follow-up at 1, 3, 6, and 12 months and annually thereafter included evaluation of symptoms, ankle-brachial index (ABI), and intra-arterial angiography for new/worsening symptoms or at follow-up between 2 and 5 years. Sustained clinical success was defined as improvement in ABI >or=0.1 and/or of symptoms without repeated target lesion revascularization. Angiographic restenosis was defined as >or=50% diameter reduction. Subgroup analysis was performed for de novo versus recurrent lesions. Mean clinical follow-up was 32.3+/-21.5 months. Angiographic follow-up was available in 83 (56%) patients (41 BA and 42 BA+EVBT) at a mean 31.8+/-20.7 months. Cumulative sustained clinical success rates at 1, 2, and 3 years, respectively, were 84.3%, 82.1%, and 76.4% after BA versus 82.4%, 69.8%, and 67.5% after BA+EVBT (p=0.26 by log-rank). Although the proportion of patients undergoing follow-up angiography was moderate, the freedom from angiographic restenosis at 1, 2, and 3 years was 70.7%, 63.1%, and 47.1% after BA versus 82.7%, 64.3%, and 64.3% after BA+EVBT (p=0.16 by log-rank). No differences were found between BA and BA+EVBT outcomes in patients with de novo versus recurrent femoropopliteal lesions. The seemingly beneficial short-term effects of BA+EVBT are not sustained in the longer term, with no robust clinical improvement after angioplasty of atherosclerotic de novo or recurrent femoropopliteal lesions at up to 5 years.

Outcome of Patients Undergoing Balloon Angioplasty in the Two Months Prior to Noncardiac Surgery

We report on the incidence of adverse cardiac events in 350 patients who underwent noncardiac surgery within 2 months of successful balloon angioplasty (BA) at our institution between 1988 and 2001. Three patients died perioperatively (n = 1) or had myocardial infarction (n = 2) (0.9%, 95% confidence interval [CI] 0.2% to 2.5%), which is a lower incidence than that reported for patients undergoing noncardiac surgery after stenting (3.9% to 32%). One patient died, and 2 had a nonfatal myocardial infarction. All 3 (1.6%, 95% CI 0.3% to 4.6%) were among the 188 patients who underwent surgery within 2 weeks of BA. Repeat target vessel revascularization was performed in 10 patients (2.9%, 95% CI 1.4% to 5.2%): in 3 (1.6%, 95% CI 0.3% to 4.6%) of 188 patients who underwent surgery within 2 weeks of BA and in 7 (5.1%, 95% CI 2.1% to 10.2%) of 138 patients who underwent surgery within 3 to 7 weeks of BA. Therefore, in patients in whom percutaneous coronary revascularization is required before noncardiac surgery, BA appears to be safe, especially in patients who need to undergo surgery early after percutaneous coronary intervention.

Percutaneous coronary intervention triggers a systemic inflammatory response in patients treated for in-stent restenosis – comparison with stable and unstable angina

It is believed that the magnitude of the systemic inflammatory response induced by percutaneous coronary intervention (PCI) impacts on the long-term outcomes in patients with stable angina (SA) and unstable angina (UA). We aimed to determine whether an inflammatory response appears in in-stent restenosis (ISR) patients undergoing balloon angioplasty and to assess its pattern and magnitude in relation to SA and UA subjects. 80 patients (59 with SA, 10 with UA, 11 with ISR) were enrolled into the prospective study. SA and UA patients undergoing single vessel coronary balloon angioplasty followed by stenting versus ISR subjects in whom only balloon angioplasty was performed. C-reactive protein (CRP), serum amyloid A (SAA), tumor necrosis factor alpha (TNF-alpha) and interleukin 10 (IL-10) were measured in blood samples collected before and 6, 24 h and 1 month after the procedure. A comparable pattern of inflammatory response in terms of CRP and SAA concentrations in subjects undergoing PCI due to ISR and SA was discovered while in unstable patients its magnitude was substantially higher. CRP and SAA levels increased significantly in each group with the peak value at 24 h and the baseline levels remarkably correlated with the highest markers' concentrations. In contrast, preprocedural TNF-alpha concentrations were higher in ISR group when compared with SA and UA patients. Additionally, in ISR group a twofold increase in their values of borderline significance at 6 h was noted. SA and UA subjects were found to have significantly lower TNF-alpha levels at 6 and 24 h after the intervention though the marker concentrations markedly increased with peak values at 1 month. The levels of IL-10 did not differ at any time point between the groups. We suggest that PCI triggers a systemic inflammatory response in patients with ISR and considerable differences in its pattern when compared with SA and UA patients were demonstrated. Moreover, a high preprocedural TNF-alpha level and its increase provoked by PCI in the ISR group warrant the need for further investigation of its possible involvement in the restenosis process.

Angioplastie primaire à long terme : quel bénéfice des endoprothèses ?

Background. – Primary stenting leads to a better short-term outcome than balloon angioplasty for acute myocardial infarction in randomised trials. However few data are available about the long-term outcome of primary stenting in acute myocardial infarction (AMI). Objectives. – The aim of this study was to compare the three-year outcome after primary stenting versus balloon angioplasty in patients with acute myocardial infarction. Methods. – We conducted a retrospective study including 157 patients with AMI in a single center. Patients underwent balloon angioplasty ( N =48) or primary stenting ( N =109) within six hours after the onset of chest pain. We looked at the outcome during three years focusing on global mortality, major adverse cardiac events (MACE), reinterventions and target vessel revascularization (TVR). Results. – The two groups are similar for their baseline characteristics. No difference was noted for in-patient mortality in the balloon angioplasty group and the primary stenting group (2.1 vs 2.8%; P =ns). The three-year mortality was not significantly different in the two groups. Regarding MACE (27.8 vs 31.7; P =0.95), reinterventions (20.4 vs 24.7 %; P =0.98) and TVR (18.6 vs 17.8%; P =0,69), both groups were statistically not different. Conclusion. – In the long-term patients treated with stent placement have similar rates of MACE, reinterventions or TVR than patients undergoing balloon angioplasty. If few studies noted a benefit in short-term outcomes, primary stenting doesn't improve the prognosis of acute myocardial infarction on long-term follow-up, which is dependent on atherosclerosis.

Clinical features and outcomes of primary percutaneous coronary intervention for subacute stent thrombosis—a case series

Subacute stent thrombosis (SAT) is an important and Three patients underwent balloon angioplasty (PTCA) most feared complication of percutaneous coronary intervention (PCI). In the modern era of dual antiplatelet therapy, the incidence of SAT is less than 1% [1]. The clinical features and outcomes of the patients who have had emergency PCI for SAT have not been well described. We performed a retrospective case analysis of the Thoraxcenter database between October 2000 and April 2002. Patients who underwent PCI for SAT were identified and formed our study population. SAT was defined as the presence of an intraluminal filling defect on coronary angiography within the stent, resulting in reduced (TIMI 0 or 1) anterograde blood flow within one month after stent implantation. During the study period, we identified nine patients who had undergone primary PCI for SAT (Table 1). The baseline and clinical characteristics were shown in the table. The original stents were deployed in the left anterior descending artery (LAD) in all nine patients. The median time to SAT occurrence was 7 days (range 1–10 days). All the patients presented with angina associated with ST segment elevation over anterior precordial leads in 12-lead electrocardiography (ECG). The cardiac enzymes were elevated with peak creatinine kinase (CPK), CKMB fraction and troponin T levels of 5135 and 349 IU/l and 14.9 ng/ml, respectively. Three patients were in cardiogenic shock. All the patients had symptom duration less than 24 h.

Frequency and time course of reocclusion and restenosis in coronary artery occlusions after balloon angioplasty versus wiktor stent implantation: results from the Mayo-Japan Investigation for Chronic Total Occlusion (MAJIC) Trial

Background Compared with balloon angioplasty, stent implantation has been shown to reduce restenosis and reocclusion after treatment of chronic total coronary artery occlusions (CTOs). However, little is known about the time course of restenosis and reocclusion after the 2 procedures. The purpose of this study was to examine the frequency and time course of restenosis and reocclusion after treatment of CTOs with balloon angioplasty and Wiktor stent implantation. Methods and results A total of 221 patients with successfully recanalized CTOs were randomly assigned to either treatment with a coil stent implantation (Wiktor stent, n = 110) or standard balloon angioplasty (n = 111). Repeat angiography was performed the day after treatment and at 6 months. Patients undergoing balloon angioplasty showed 29.8% restenosis and 1.1% reocclusion the following day versus 2% restenosis and no reocclusion in stent patients the following day. The cumulative reocclusion rate was significantly lower in the stent group than in the balloon group at 6 months (2.1% versus 9.3%, P < .05). As a result of the more frequent need of target vessel revascularization (49.5% in the balloon group and 30.6% in the stent group, P < .005) and earlier final follow-up angiography in the balloon group, the frequency of angiographic restenosis at 6 months was similar in both groups (57.3% in the stent group and 54.5% in the balloon group). Conclusions The frequency and time course of reocclusion and restenosis after balloon angioplasty and stent placement differ within 24 hours of the procedure and remain different on angiography at 6 months.

Treatment of coronary stent thrombosis with rheolytic thrombectomy: Results from a multicenter experience

The objective of this study was to assess the feasibility, efficacy, and safety of rheolytic thrombectomy (RT) for treatment of coronary stent thrombosis. Stent thrombosis is an infrequent but potentially devastating complication. Conventional treatment with balloon angioplasty and/or thrombolysis has yielded suboptimal results. RT was used to treat 18 patients (mean age, 62 +/- 8 years; 72% male) with in-stent thrombosis (mean time to stent thrombosis, 2.4 +/- 1.8 days). Device success, procedure success, in-hospital and 30-day major cardiovascular events (MACE) were assessed in the hospital and at 30 days. Device success was obtained in 94% and procedure success was achieved in 100% of patients. Following RT, 11 patients underwent balloon angioplasty and 7 patients received additional stents. TIMI 3 coronary flow was obtained in 94.4% and all (100%) patients achieved either TIMI 2 or 3 coronary flow. The angiographic thrombus area decreased from 113.7 +/- 79 to 5.5 +/- 5.7 mm(2) after RT, and to 0.9 +/- 2.1 mm(2) (P < 0.001) after final treatment. Procedural complications were limited to transient no-reflow in five patients. Only one patient evolved a Q-wave MI. At 30 days of follow-up, no patients suffered death, emergent bypass surgery, or stroke. Our data suggest that the adjunctive use of rheolytic thrombectomy offers improved outcomes compared to prior results of intervention after coronary stent thrombosis and should be strongly considered as a treatment option for this complication.

Comparison of intracoronary gamma radiation for in-stent restenosis in saphenous vein grafts versus native coronary arteries

Intracoronary gamma radiation is effective in reducing recurrent in-stent restenosis (ISR) involving native coronary arteries. This study compares the effectiveness and safety of intracoronary gamma radiation for the treatment of ISR in saphenous vein grafts (SVGs) versus native coronary arteries. In the Washington Radiation for In-Stent restenosis Trial (WRIST) series of gamma radiation trials, 1,142 patients with ISR (230 in SVG and 912 in native coronary arteries) completed 6-month clinical follow-up. All patients underwent balloon angioplasty, atherectomy, and/or restenting. Different ribbon lengths containing 6 to 23 seeds of iridium-192 were used to cover lesion lengths <80 mm. The prescribed radiation doses were 14 or 15 Gy at 2-mm radial distance from the center of the source. Baseline demographics showed that patients with SVGs were older (65 ± 13 vs 61 ± 11 years, p <0.001), more likely male (79% vs 64%, p <0.001), had more multivessel coronary disease (81% vs 50%, p <0.001), and less diffuse lesions (17 ± 10 vs 24 ± 12 mm, p <0.001). At 6 months, event-free survival was similar for patients with SVG ISR and native coronary ISR (82% vs 84%, p = 0.35). The SVG ISR population had a low rate of late total occlusion (4.6%) and late thrombosis (3.5%). Thus, treatment of ISR with gamma radiation in SVGs had similar outcome to native coronary arteries. The use of gamma radiation for the treatment of ISR should expand to SVGs.

Correlates of coronary blood flow before and after percutaneous coronary intervention and their relationship to angiographic and clinical outcomes in the RESTORE trial

Background and Objectives Slower blood flow in the setting of acute myocardial infarction (MI) has been related to adverse outcomes, but the relationship of coronary blood flow after percutaneous transluminal coronary angioplasty (PTCA) in the setting of acute coronary syndromes to adverse outcomes and restenosis has not been well described. We sought to evaluate the correlates of pre- and post-PTCA coronary blood flow to shed light on potential modifiable determinants. Methods The RESTORE trial (Randomized Efficacy Study of Tirofiban for Outcomes and REstenosis) was a randomized, double-blind, placebo-controlled trial of tirofiban in patients undergoing balloon angioplasty or directional atherectomy within 72 hours of occurrence of either unstable angina pectoris or acute MI. Coronary blood flow was assessed with the corrected TIMI frame count (CTFC), and clinical outcomes were assessed at 30 days. Results In addition to tighter and longer minimum lumen diameters (MLDs), the multivariate correlates of slower flow before PTCA also included the presence of thrombus, collaterals, left coronary artery lesion location, acute MI, and >8F catheter size. As well as the above variables, type C and D dissection grades were related to slower post-PTCA CTFC. Death, or the composite of death/MI/coronary artery bypass graft at 30 days, was more frequent among patients with slower post-PTCA CTFCs and those with post-PTCA thrombus. In a multivariate model correcting for reference segment diameter and MLD, the post-PTCA CTFC was an independent predictor of late lumen loss and the follow-up MLD at 6 months. As a single index that integrates functional and anatomical aspects of the post-PTCA results, the ratio of CTFC/MLD was associated with death/MI by 30 days. Conclusions In addition to MLD, variables such as the presence of thrombus, left coronary artery lesion location, and dissection grade also are associated with slower coronary blood flow after PTCA. In turn, post-PTCA CTFCs were an independent predictor of late lumen loss and follow-up MLDs. Furthermore, patients who die or who sustain other adverse cardiac events have slower coronary blood flow and greater thrombus burden after PTCA. (Am Heart J 2002;144:130-5.)

Does ticlopidine reduce reocclusion and other adverse events after successful balloon angioplasty of occluded coronary arteries? Results from the Total Occlusion Study of Canada (TOSCA)

Objectives Ticlopidine reduces stent thrombosis and other adverse events among patients receiving coronary stents. Whether ticlopidine is beneficial after balloon angioplasty is unknown. Our purpose was to compare the clinical outcome of patients undergoing balloon angioplasty treated with both aspirin and ticlopidine versus aspirin alone. Methods and Results We performed a databank analysis of the Total Occlusion Study of Canada (TOSCA), a randomized trial with angiographic follow-up comparing the frequency of reocclusion after angioplasty of a subtotal or total coronary occlusion in patients receiving ≥1 heparin-coated Palmaz-Schatz stent versus balloon angioplasty alone. In TOSCA, 102 patients undergoing balloon angioplasty were treated with both aspirin and ticlopidine (generally for 15-30 days) and 94 were treated with aspirin alone, by physician preference. After 6 months, failure to sustain patency (less than Thrombolysis in Myocardial Infarction [TIMI] grade 3 flow on follow-up angiography) occurred in 23% of patients on ticlopidine and aspirin versus 16% of patients on aspirin alone (P =.21); the frequency of target vessel revascularization was also similar in the 2 groups (32% vs 25%, P =.27). Myocardial infarction was infrequent in both groups (2.0% vs 1.1%, respectively, P not significant). Patients treated with aspirin and ticlopidine had more adverse angiographic and procedural characteristics, including longer lesions and treatment lengths. Multivariate analysis to adjust for these and other differences failed to reveal a benefit of ticlopidine in maintaining patency and reducing adverse clinical events. Conclusions After balloon angioplasty of a subtotal or total coronary occlusion, no reduction in adverse events was observed among patients in whom ticlopidine was added to aspirin, even after adjustment for clinical and lesion characteristics. (Am Heart J 2001;142:776-81.)

Uncomplicated moderate coronary artery dissections after balloon angioplasty: good outcome without stenting

OBJECTIVETo study the relation between moderate coronary dissections, coronary flow velocity reserve (CFVR), and long term outcome.METHODS523 patients undergoing balloon angioplasty and sequential intracoronary Doppler measurements were examined as part of the DEBATE II trial (Doppler endpoints balloon angioplasty trial Europe). After successful balloon angioplasty, patients were randomised to stenting or no further treatment. Dissections were graded at the core laboratory by two observers and divided into four categories: none, mild (type A-B), moderate (type C), severe (types D to F). Patients with severe dissections (n = 128) or without available reference vessel CFVR (n = 139) were excluded. The remaining 256 patients were divided into two groups according to the presence (group A, n = 45) or absence (group B, n = 211) of moderate dissection.RESULTSFollowing balloon angioplasty, there was no difference in CFVR between the two groups. At 12 months follow up, a higher rate of major adverse cardiac events was observed overall in group A than in group B (10 (22%)v 23 (11%), p = 0.041). However, the risk of major adverse events was similar in the subgroups receiving balloon angioplasty (group A, 6 (19%) v group B, 16 (16%), NS). Among group A patients, the adverse events risk was greater in those randomised to stenting (odds ratios 6.603v 1.197, p = 0.046), whereas there was no difference in risk if the group was analysed according to whether the CFVR was &lt; 2.5 or ⩾ 2.5 after balloon angioplasty.CONCLUSIONSModerate dissections left untreated result in no increased risk of major adverse cardiac events. Additional stenting does not improve the long term outcome.

The benefit of abciximab in percutaneous coronary revascularization is not device-specific

Abciximab has been shown to decrease adverse outcomes after percutaneous coronary interventions, but it is unclear whether this beneficial effect is more or less pronounced with specific devices. This study sought to determine the relative magnitude of the benefit of abciximab among different interventional devices. Data from the 5 placebo-controlled trials of abciximab during coronary intervention were pooled. Patients were divided into groups based on whether they received balloon angioplasty alone, elective stenting, bailout stenting, or directional coronary atherectomy. In the patients undergoing balloon angioplasty, the 30-day hazard ratio for death or myocardial infarction (MI) in the group randomized to abciximab versus the placebo-treated group was 0.52 (p <0.001), for elective stenting the hazard ratio was 0.51 (p <0.001), for bailout stenting the hazard ratio was 0.38 (p <0.001), and for directional coronary atherectomy the hazard ratio was 0.38 (p = 0.007). A Cox proportional-hazards model revealed that overall, the use of abciximab decreased the composite end point of 30-day death or MI rates (hazard ratio 0.55, 95% confidence interval 0.43 to 0.69, p <0.001). However, bailout stenting and directional coronary atherectomy were associated with increased rates of death or MI compared with balloon angioplasty, as was elective stenting in women compared with men. There was no significant increase in major bleeding episodes associated with abciximab in any of the device categories. These findings from all the controlled coronary revascularization trials using abciximab demonstrate that a decrease in death and MI is achieved with abciximab regardless of the type of device used, without an increase in significant bleeding complications.

Physiologically assessed coronary collateral flow and intracoronary growth factor concentrations in patients with 1- to 3-vessel coronary artery disease.

The purpose of this study was to test the hypothesis that there is a relation between collateral flow and intracoronary concentrations of basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) and that the combined concentrations of both growth factors and the extent of coronary artery disease (CAD) play a role as covariables in such an association. In 76 patients undergoing balloon angioplasty, a collateral flow index (CFI, no units) was determined with sensor-tipped guidewires. Simultaneously, serum concentrations of bFGF and VEGF, obtained at the aortic root from the ostium of the collateralized coronary artery (n = 76) and from the distal position of the occluded coronary artery (n = 34), were determined. There was a direct correlation between CFI and distal VEGF (r = 0.33, P = 0.05) but not bFGF concentrations. Focusing on the proximal sampling site, there was a direct correlation between CFI and both bFGF (r = 0.29, P = 0.01) and VEGF concentrations (r = 0.44, P < 0.0001). The sum of the concentrations of both growth factors was directly associated with CFI irrespective of the proximal (r = 0.51, P < 0.0001) or distal sampling site (r = 0.34, P = 0.048). There was a trend toward higher proximal VEGF concentrations in patients with higher numbers of coronary stenotic lesions (r = 0.25, P = 0.03). In patients with CAD, there is an association between a directly measured index of collateral flow and intracoronary concentrations of bFGF and VEGF. This direct relation is dependent on the site of blood sampling within the coronary artery tree. The association is closest when the combined bFGF and VEGF concentrations are taken into account. In the case of VEGF, it is influenced by the degree of coronary atherosclerosis.

Neointimal formation after balloon-induced vascular injury in Yucatan minipigs is reduced by oral rapamycin.

Rapamycin, a macrolide antibiotic known to prevent allograft rejection, is a potent inhibitor of cell proliferation. Therefore we studied the effects of orally administered rapamycin in a pig model of balloon injury in an attempt to reduce the cellular proliferation and neointimal formation thought to play a role in restenosis. Twenty Yucatan minipigs, divided into groups of 10 animals each, were subjected to balloon inflation of the carotid arteries. One group received the methylcellulose vehicle for rapamycin, whereas the second group was treated for a total of 31 days with 2.0 mg/kg of rapamycin administered daily by oral gavage. This dose and treatment regimen produced significant (p < 0.05) reductions in neointimal area (59%) and in the maximal thickness of the neointima (59%) when comparisons were made with vehicle-treated animals. These effects were accompanied by a significant increase in the lumen area in animals that received rapamycin (33%). Medial area was decreased by 18% in these animals. Blood samples from rapamycin-treated pigs indicated peak concentrations of 1.87 +/- 0.45 and 1.70 +/- 0.24 ng/ml at 2 and 4 weeks after balloon angioplasty, respectively. Significant increases in blood pressure of 21 mm Hg and decreases in heart rate of 25 beats/min also were observed in rapamycin-treated animals relative to those that received vehicle. These results indicate that the antiproliferative effect of rapamycin can be demonstrated after oral dosing in a pig vascular injury model, suggesting a possible therapeutic utility for rapamycin or its analogs in patients undergoing balloon angioplasty.

Systemic and translesional activation of coagulation, fibrinolytic, and inhibitory systems in candidates for coronary angioplasty: Basal state and effect of successful dilation

Objectives Thrombosis is a major contributor to complications associated with coronary interventions. It is unclear whether patients who have undergone angioplasty are predisposed to thrombus formation because of underlying perturbations in their hemostatic equilibrium. Methods Concentration or activity was measured for 14 plasma proteins involved in the coagulation, fibrinolytic, and inhibitory systems. Baseline systemic measurements were compared between patients undergoing balloon angioplasty (n = 15) and normal subjects (n = 32), with sampling repeated at the end of the procedure. To better assess the local hemostatic environment near the site of dilation, intracoronary arterial samples were also obtained just proximal and distal to the dilated stenosis. Results Multiple differences in measured coagulation proteins were found at baseline between the angioplasty candidates and control subjects, including higher mean concentration of plasma fibrinogen (P <.001) and lower high-molecular-weight kininogen concentration (P <.01) and factor XII activity (P <.01). Concentrations of the inhibitory proteins antithrombin III and protein S also differed significantly (P <.001 and P <.01, respectively), with a trend toward lower protein C concentration as well (P <.05). Finally, heightened fibrinolysis was suggested by a marked increase in mean plasma d -dimer concentration in the angioplasty candidates (293 ± 191 ng/mL vs 116 ± 31 ng/mL, P <.01), with a more modest increase in tissue plasminogen activator (P <.05) and decrease in α2 -antiplasmin (P <.001). Importantly, none of the parameters obtained during the procedure differed significantly from samples obtained before and after angioplasty, and no translesional gradients were observed. Conclusions Patients with active ischemic syndromes who are considered candidates for coronary angioplasty demonstrate significant and multiple alterations in their coagulation, inhibitory, and fibrinolytic systems. However, no further changes were observed during coronary dilation, either systemically or locally, after pretreatment with typical doses of heparin and aspirin. (Am Heart J 1999;137:274-83.)